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NCT01430403 · ClinicalTrials.gov registry record · Phase 4
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 478
- Enrollment target
NCT01430403 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 478 participants.
The verdict
NCT01430403, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 478 participants
- Enrollment target
Study Summary
The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.
Interventions
- BIOLOGICAL Omalizumab
- BIOLOGICAL Placebo omalizumab
- DRUG Inhaled Corticosteroid Boost Therapy (ICS)
- BIOLOGICAL Placebo fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01430403
The ClinicalTrials.gov registry entry for NCT01430403 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Omalizumab is the first listed.
NCT01430403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01430403 about?
NCT01430403 is a clinical study titled "Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations". The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to t...
What is the current status of trial NCT01430403?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 478 participants. The study started on 2011-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01430403?
The interventions under investigation include: Omalizumab (BIOLOGICAL), Placebo omalizumab (BIOLOGICAL), Inhaled Corticosteroid Boost Therapy (ICS) (DRUG), Placebo fluticasone (BIOLOGICAL).
Who is sponsoring clinical trial NCT01430403?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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